Effects of a Kappa Agonist on Hot Flashes in Menopausal Women

NCT02070718 ↗

Phase 1 Completed 12 enrolled University of Washington Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab National Center for Advancing Translational Sciences (NCATS) · collab National Center for Complementary and Integrative Health (NCCIH) · collab National Institute on Aging (NIA) · collab Office of Research on Women's Health (ORWH) · collab

RandomizedCrossoverQuadruple-blindTreatment

Summary

Studies suggest that kappa agonists (KA) and peripherally restricted kappa agonists (PRKAs) may affect thermoregulation. This pilot study has the aim to establish proof of concept regarding efficacy of an oral kappa agonist (KA) for the treatment of menopausal hot flashes.

Timeline

Start: 2013-01
Primary completion: 2013-07
Completion: 2013-07

Outcome

Met primary endpoint

paper hot flash frequency 2 to 7 hours after therapy initiation was lower than that for placebo PMID 25988798 ↗

paper placebo, 5.94 [0.78] hot flashes per 5 h; P = 0.025 PMID 25988798 ↗

Publications

Oakley AE, Steiner RA, Chavkin C, Clifton DK, Ferrara LK, Reed SD. kappa Agonists as a novel therapy for menopausal hot flashes. Menopause. 2015 Dec;22(12):1328-34. doi: 10.1097/GME.0000000000000476.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naloxone	Small molecule	0.25 mg	Oral
Subject	Naloxone	Small molecule	0.5 mg	Oral
Subject	pentazocine	Unknown	25 mg	Oral
Subject	pentazocine	Unknown	50 mg	Oral

Indications

No indication recorded.